Micro-needle bladder balloon

ABSTRACT

Devices and methods for delivering treatment fluids or particulates such as, stem cells, drugs, Botox and like, to an inner lining of a bladder for treatment of urinary tract disorders, including over-active bladder. A balloon delivery system can include an inflation balloon having a plurality of micro-needles configured to pierce and otherwise puncture an inner bladder wall so as to deliver the treatment fluid to bladder tissue. The treatment fluid can be directly injected into the bladder tissue using the micro needles. Alternatively, the micro needles can be fabricated of bioabsorbable or bioresorbable materials such that the micro needles can remain embedded within the bladder tissue to deliver the treatment fluid or particulate.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of, and claims priority to, U.S.patent application Ser. No. 13/993,752, filed on Aug. 26, 2013, entitled“MICRO-NEEDLE BLADDER BALLOON”, which is a National Phase entry of PCTApplication No. PCT/US2011/065468, filed on Dec. 16, 2011, which claimspriority from U.S. Provisional Application No. 61/423,732, filed on Dec.16, 2010, the disclosures of which are incorporated by reference hereinin their entirety.

FIELD OF THE INVENTION

The invention relates generally to urinary disorder treatment tools andmethods. More specifically, the present invention is directed to adevice, system and method of introducing stem cells to a patient'sbladder tissue using an inflation balloon having a plurality ofmicro-needles.

BACKGROUND OF THE INVENTION

Urinary incontinence is a significant health concern worldwide. Forexample, lower urinary tract disorders affect the quality of life ofmillions of men and women in the United States every year. Thesedisorders include overactive bladder. Overactive bladder is a treatablemedical condition that is estimated to affect 17 to 20 million people inthe United States. Current treatments for overactive bladder includemedication, diet modification, programs in bladder training, electricalstimulation, and surgery. There is a continuing desire to provideadditional treatment options that can be used as an alternative to, orin conjunction with, the current treatment options.

SUMMARY OF THE INVENTION

The present invention relates generally to devices and method fordelivering treatment fluids or particulates such as, stem cells, drugs,Botox and like, to an inner lining of a bladder for treatment of urinarytract disorders, including over-active bladder. In the variousembodiments, an inflation balloon includes micro-needles configured topierce and otherwise puncture the inner bladder walls so as to deliverthe treatment fluid to bladder tissue. Various embodiments of theinvention allow the treatment fluid to be injected into the bladdertissue using the micro needles. Alternatively, the micro needles can befabricated of bioabsorbable or bioresorbable materials such that themicro needles can remain embedded within the bladder tissue to deliverthe treatment fluid or particulate.

In one aspect of the present invention, a balloon delivery system cancomprise an inflation balloon fabricated so as to include a plurality ofmicro needles attached to an exterior surface of the inflation balloon.Following placement of the inflation balloon within the bladder, theinflation balloon can be fully inflated so as to come into contact withan inner wall of the bladder such that tips of the micro needle comeinto contact, pierce and enter the bladder tissue. Once embedded withinthe bladder tissue, a treatment fluid is delivered into the bladdertissue. In some embodiments, an internal inflation balloon can beinflated to pressurize the treatment fluid and otherwise force theinflation fluid through the micro needles for injection into the bladdertissue. In some embodiments, the micro needles can be formed of abioabsorbable or bioresorbable material wherein the micro needlesinclude barbs such the micro needles break off and remain embeddedwithin the bladder tissue upon deflation of the inflation balloon. Insome embodiments, the micro needles can be included on an internalinflation balloon that upon inflation, pierce a second inflation balloonthat is in contact with the inner bladder wall, prior to the microneedles contacting and piercing the inner bladder wall. In someembodiments, the micro needles can be formed using the material of theinflation balloon.

In another aspect of the present invention, a balloon delivery systemcan include a lead structure that is introduced to the bladder within aninflation balloon. The lead structure can comprise a lead lumen that isfluidly connected to a central lead hub. A plurality of micro needlescan be fluidly connected to the lead hub using individual flexibledelivery tubes. The lead structure can be advanced through a catheterbody such that the lead hub is positioned within the inflation balloon.Treatment fluid can be directed into the lead lumen, whereby thepressure of the treatment fluid causes the micro needles to deployoutwardly from the lead hub. As each micro needle approaches theinflation balloon, the pressure of the treatment fluid causes the microneedle to sequentially puncture the inflation balloon and internalbladder wall such that the micro needle can inject the treatment fluidinto the bladder tissue. Following injection of the treatment fluid, thelead structure can be withdrawn from the inflation balloon.

In another aspect of the present invention, a balloon delivery systemcan include an inflation balloon wherein an exterior surface of theinflation balloon has been modified to from micro needles from thematerial of the inflation balloon itself. In some embodiments, aplurality of raised dimples can be formed in the exterior surfacewherein each dimple defines a micro needle capable of piercing orotherwise puncturing an inner bladder wall for delivery of a treatmentfluid to bladder tissue. In some embodiments, the exterior surface caninclude a plurality of recessed portions including a micro needle thatcan be deployed outwardly and into the inner bladder wall under theinfluence of a pressurized treatment fluid. In some embodiments, aninternal inflation balloon can be utilized to pressurize the treatmentfluid. The internal inflation balloon can include one or more well forstoring the treatment fluid prior to its injection through the microneedles.

The above summary of the various representative embodiments of theinvention is not intended to describe each illustrated embodiment orevery implementation of the invention. Rather, the embodiments arechosen and described so that others skilled in the art can appreciateand understand the principles and practices of the invention. Thefigures in the detailed description that follow more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention can be completely understood in consideration of thefollowing detailed description of various embodiments of the inventionin connection with the accompanying drawings, in which:

FIG. 1 is a schematic representation of a urinary tract system includingan inflation balloon catheter and drain catheter positioned therein

FIG. 2 is a schematic representation of a urinary tract system includinga partially inflated inflation balloon and drain catheter positionedtherein.

FIG. 3 is a schematic representation of a urinary tract system includinga fully inflated inflation balloon and drain catheter positionedtherein.

FIG. 4 is a partial section view of a balloon delivery system accordingto an embodiment of the present invention.

FIG. 5 is a partial side view of an inflation balloon for use with theballoon delivery system of FIG. 4 .

FIG. 6 is a schematic representation of a balloon delivery systemaccording to an embodiment of the present invention.

FIG. 7 is a partial section view of the balloon delivery system of FIG.6 .

FIG. 8 is a partial section view of a balloon delivery system accordingto an embodiment of the present invention.

FIG. 9 is a partial section view of a balloon delivery system accordingto an embodiment of the present invention.

FIG. 10 is a partial section view of the balloon delivery system of FIG.9 .

FIG. 11 is a schematic representation of a balloon delivery systemaccording to an embodiment of the present invention.

FIG. 12 is a schematic representation of a balloon delivery systemaccording to an embodiment of the present invention.

FIG. 13 is a perspective view of a portion of an inflation balloon foruse with the balloon delivery system of FIG. 12 .

FIG. 14 is a perspective view of the inflation balloon of FIG. 13 .

FIG. 15 is a perspective view of the inflation balloon of FIG. 13 .

FIG. 16 is a partial section view of the balloon delivery system of FIG.12 .

FIG. 17 is a partial section view of the balloon delivery system of FIG.12 .

FIG. 18 is a schematic representation of a balloon delivery systemaccording to an embodiment of the present invention.

FIG. 19 is a partial section view of the balloon delivery system of FIG.18 .

FIG. 20 is a partial section view of the balloon delivery system of FIG.18 .

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit the invention to theparticular embodiments described. On the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present invention is directed to devices, instruments, assembliesand methods for delivering an injectable treatment such as, for example,stem cells or medicants such as Botox and the like, to an inner liningof the bladder for treatment of urinary tract disorders, includingover-active bladder (OAB).

As illustrated in FIG. 1 , a urinary tract 100 of a representativeindividual includes a bladder 102 that is fluidly connected with aurethra 104. Bladder 102 generally accumulates a bodily fluid 106, i.e.urine that flows through urethra 104 prior to being discharged from thebody. As illustrate, a balloon catheter 108 and a drain catheter 110have been slidingly positioned within the urinary tract 100. Ballooncatheter 108 generally includes a catheter body 112 defined between adistal treatment end 114 and a proximal biasing end (not shown) thatremains external to the patient's body. Drain catheter 110 generallyincludes a drain catheter body 116 having a distal draining end 118 anda proximal draining end (not shown) that remains external to thepatient's body. Attached to the distal treatment end 114 of the ballooncatheter 108 is an inflation balloon 120. Generally, inflation balloon120 is inserted into the urinary tract 100 with the inflation balloon120 in an uninflated disposition 122. Drain catheter 110 is generallyinserted such that a drain lumen 124 is positioned just inside thebladder 102.

As illustrated in FIG. 2 , inflation balloon 120 can begin to beinflated to a partially inflated disposition 126 utilizing an inflationfluid such as saline or air that is introduced through the ballooncatheter 108. As the inflation balloon 120 is inflated, bodily fluid 106is expelled from the bladder 102 through the drain lumen 124 whereby thebodily fluid 106 travels through the drain catheter 110 and out theurinary tract 100. As illustrated in FIG. 3 , inflation balloon 120 iseventually inflated to a fully inflated disposition 128 wherein theinflation balloon 120 is in direct contact with an inner bladder wall130 and all of the bodily fluid 106 has been evacuated from bladder 102.For purposes of clarity, the Figures generally show a gap between theinflation balloon 120 and the inner bladder wall 130 though it is to beunderstood that in practice, the inflation balloon 120, when inflated tofully inflated disposition 128, will be in direct physical contact withthe inner bladder wall 130.

Referring now to FIGS. 4 and 5 , a representative balloon deliverysystem 200 of the present invention can comprise inflation balloon 120including a plurality of micro needles 202 attached to an exteriorballoon surface 204 of the inflation balloon 120. Each micro needle 202generally includes an injection lumen 204 defined between an inletaperture 205 and an injection aperture 206 located at a needle tip 208.Balloon delivery system 200 can further comprise an internal inflationballoon 210 that is located internal to the inflation balloon 120,wherein operation of the internal inflation balloon 210 is independentof the inflation of inflation balloon 120.

In using representative balloon delivery system 200, inflation balloon120 is fully inflated while any bodily fluid 106 is evacuated from thebladder 102. As inflation balloon 120 approaches fully inflateddisposition 128, each needle tip 208 begins to contact the inner bladder25 wall 130 such that when inflation balloon 120 achieves the fullyinflated disposition 128, each needle tip 128 has punctured or otherwiseperforated the inner bladder wall 130 with the injection aperture 206being fully imbedded within bladder tissue 132. Next, a treatment fluid212 can be introduced into the inflation balloon 120 through thecatheter body 112. Treatment fluid 212 can include a variety oftreatment modalities including, for example, stem cells, drugs andmedicants such as Botox. With the treatment fluid 212 introduced to theinflation balloon 120, internal inflation balloon 210 can be advancedinto the inflation balloon 120 through the catheter body 112. Internalinflation balloon 210 generally includes its own inflation lumen suchthat internal inflation balloon 210 can be individually inflated withininflation balloon 120. As internal inflation balloon 210 is inflated,treatment fluid 212 which is present between the inflation balloon 120and internal inflation balloon 210 is pressurized such the treatmentfluid 212 enters each inlet aperture 205 for subsequent injection intothe bladder tissue 132. As internal inflation balloon 210 approaches afully inflated state in which the internal inflation balloon 210contacts the inflation balloon 120, all of the treatment fluid 212 isforcibly directed into the bladder tissue 132 through the micro needles202. The rate of delivery of treatment fluid 212 through the microneedles 202 can be controlled by decreasing or increasing the pressurein the internal inflation balloon 210. In some representativeembodiments, each injection lumen 204 can have a diameter of at leastabout 0.337 mm and can be capable of delivering 30 mL of treatment fluid212.

In a variation of balloon delivery system 200 as illustrated in FIGS. 6and 7 , the micro needles 202 can be operably coupled to an exteriorsurface 220 of the internal inflation balloon 210. Once again, inflationballoon 120 is fully inflated to evacuate any bodily fluid 106 from thebladder 102. With inflation balloon 120 in fully inflated disposition128 and in direct contact with inner bladder wall 130, internalinflation balloon 210 can be advanced into the inflation balloon 120.Internal inflation balloon 210 can then be inflated causing the microneedles 202 to approach and ultimately puncture the inflation balloon120 and inner bladder wall 130 such that each needle tip 208 enters thebladder tissue 132. Treatment fluid 212 can be introduced into theinternal inflation balloon 210 wherein a third internal inflationballoon 222 can be inserted into internal inflation balloon 210.Inflation of the third internal inflation balloon 222 causes treatmentfluid 212 to become pressurized such that it is then forcibly directedinto the bladder tissue 132 through the micro needles 202.

In a variation of balloon delivery system 200 as illustrated in FIG. 8 ,inflation balloon 120 can be constructed such that micro needles 202 areconstructed to require a minimum injection pressure prior to treatmentfluid 212 entering the inlet aperture 205. For instance, a diameter ofthe injection lumen 204 may necessitate a certain fluid pressure beachieved before a surface tension of treatment fluid 212 is exceeded,whereby the treatment fluid 212 can enter the inlet aperture 205.

Once again, inflation balloon 120 is fully inflated while any bodilyfluid 106 is evacuated from the bladder 102. As the inflation balloon120 approaches fully inflated disposition 128, each needle tip 208begins to contact the inner bladder wall 130 such each needle tip 128punctures or otherwise perforates the inner bladder wall 130 with theinjection aperture 206 being fully imbedded within bladder tissue 132.Treatment fluid 212 can be directly introduced into the inflationballoon 120 through the catheter body 112, whereby the treatment fluid212 can be pressurized to exceed the minimum injection pressure andinjection of the treatment fluid 212 into the bladder tissue 132 can beaccomplished.

In an alternative embodiment of a balloon delivery system 300 asillustrated in FIGS. 9 and 10 , inflation balloon 120 can comprise aplurality of barbed micro needles 302. Each barbed micro needle 302 cancomprise an insertion tip 304 and a plurality of individual barbs 306.Barbed micro needle 302 can be generally formed of a bioabsorbable orbioresorbable material such as, for example, polymers and copolymers ofpolylactides, polyglycolides and like. Barbed micro needle 302 isgenerally molded from the bioabsorbable or bioresorbable material andcan be overmolded, insert molded or otherwise attached to the inflationballoon 120 during fabrication of the inflation balloon 120. Barbedmicro needle 302 can include an internal reservoir 308 for retaining anamount of the treatment fluid 212. Alternatively, treatment fluid 212can be included within the bioabsorbable or bioresorbable materialduring forming of the barbed micro needle 302. In some embodiments,treatment fluid 212 can be replaced with a treatment particulate that ismolded into the barbed micro needle 302.

With balloon delivery system 300, the inflation balloon 120 is fullyinflated while any bodily fluid 106 is evacuated from the bladder 102.As the inflation balloon 120 approaches fully inflated disposition 128,the insertion tip 304 of each barbed micro needle 302 begins to contactthe inner bladder wall 130 such that when inflation balloon 120 is infully inflated disposition 128, the barbed micro needle 302 includingthe barbs 306 is fully embedded within bladder tissue 132. Next, theinflation fluid within the inflation balloon 120 can be removed therebycausing inflation balloon 120 to retract and return to the uninflateddisposition 122. As the inflation balloon 120 deflates, the barbs 306resist the removal of the barbed micro needles 302 from within bladdertissue 132 such that ultimately, each barbed micro needle 302 breaks offand separates form the inflation balloon 120. As such, each barbed microneedle 302 remains embedded within the bladder tissue 132 such that thetreatment fluid 212, or solid treatment particulates, are administeredduring the time period in which the bioabsorbable or bioresorbablematerials are broken down by the body.

In an alternative embodiment of a balloon delivery system 400 asillustrated in FIG. 11 , the balloon delivery system can include a leadstructure 402 that is ultimately introduced inside inflation balloon120. Generally, the lead structure 402 can include a lead lumen 404 thatis fluidly connected to a lead hub 406. A plurality of micro needles 408are fluidly connected to the lead hub 406 with flexible delivery tubes410.

Generally, the inflation balloon 120 can be advanced into the bladder102 and inflated to the fully inflated disposition 128 such that all ofthe bodily fluid 106 has been evacuated from within bladder 102. Leadstructure 402 can be advanced through the catheter body 112 such thatthe lead hub 406 is located within the inflation balloon 120. Treatmentfluid 112 can then be directed into the lead lumen 404, whereby thepressure of the treatment fluid 112 causes the micro needles 408 todeploy outwardly from the lead hub 406. As each micro needle 408approaches the inflation balloon 120, the pressure of the treatmentfluid 112 causes the micro needle 408 to sequentially puncture theinflation balloon 120 and internal bladder wall 130 such that the microneedle 408 can inject the treatment fluid 112 into the bladder tissue132. Following injection of the treatment fluid 112, the lead structure102 can be withdrawn from the inflation balloon 120.

In another alternative embodiment of a balloon delivery system 500 asillustrated in FIGS. 12, 13, 14 and 15 , inflation balloon 120 caninclude an exterior surface 502 that is manipulated to form a pluralityof micro needles 504 from the balloon material itself. As seen in FIGS.14 and 15 , inflation balloon 120 can include an interior surface 506into which a needle 508 is directed into, wherein the needle 508 is asadvanced through the inflation balloon 120 and out the exterior surface502. As the needle 508 is pulled from the exterior surface 502, a raiseddimple 510 is created that ultimately forms the micro needles 504.Preferably, the inflation balloon 120 is fabricated of a generally stiffmaterial such that raised dimples 502 and micro needles 504 are capableof puncturing the inner bladder wall 130. Once again, the inflationballoon 120 can be inflated such that the micro needles 504 are incontact and ultimately puncture the bladder wall 130 as shown in FIG. 16. Treatment fluid 112 within the inflation balloon 120 can bepressurized with an internal inflation balloon 512 such that thetreatment fluid 112 is injected into the bladder tissue 132 throughmicro needles 504.

In a variation of balloon delivery system 500, the treatment fluid 112can be stored or otherwise provided in a plurality of wells 520 arrangedabout an exterior surface 522 of the internal inflation balloon 512 asshown in FIG. 17 . Once the inflation balloon 120 has been fullyinflated such that the micro needles 504 have puncture the inner bladderwall 130, the internal inflation balloon 512 can be inflated such thatas the internal inflation balloon 512 reaches a fully inflated state,the treatment fluid 512 is ejected from the wells 520 for injectionthrough the micro needles 504.

In another alternative embodiment of a balloon delivery system 600, aninflation balloon 120 can include a plurality or recessed areas 602defined in an exterior balloon surface 604 as shown in FIGS. 18, 19 and20 . Each recessed area 602 can include a micro needle 606 and a pair ofhinge portions 608 a, 608 b. Generally, inflation balloon 120 isinserted into bladder 102 wherein the inflation balloon 120 can beinflated to come into contact with the inner bladder wall 130. Aninternal inflation balloon 610 can then be inserted into the inflationballoon 120 and inflated such that as the internal inflation balloon 610reaches a fully inflated state, treatment fluid 112 becomes pressurized.The pressure of treatment fluid 112 causes the hinge portions 608 a, 608b to transition such that the recessed area 602 is pushed toward theinner bladder wall 130. As the recessed area 602 is pushed outward, themicro needle 606 pierce and puncture in the inner bladder wall 130 andbecomes embedded within the bladder tissue 132 whereby the treatmentfluid 112 is injected into the bladder tissue 132 through micro needle606.

Although specific examples have been illustrated and described herein,it will be appreciated by those of ordinary skill in the art that anyarrangement calculated to achieve the same purpose could be substitutedfor the specific examples shown. This application is intended to coveradaptations or variations of the present subject matter. Therefore, itis intended that the invention be defined by the attached claims andtheir legal equivalents, as well as the following illustrativeembodiments.

What is claimed is:
 1. A balloon delivery system for delivering atreatment fluid to bladder tissue, comprising: a balloon catheterincluding a catheter body having a distal treatment end, the distaltreatment including an inflation balloon, the balloon catheter includinga lead lumen operatively coupled to a hub disposed within the inflationlumen, and a plurality of micro needles operatively coupled to the hub,each micro needle including a lumen and a needle tip configured topuncture an inner bladder wall for delivery of a treatment medicant intobladder tissue, each micro needle puncturing the inner bladder wall whenan inflation balloon is disposed in an inflated disposition.
 2. Theballoon delivery system of claim 1, wherein the plurality of microneedles are formed directly on an exterior surface of the inflationballoon.
 3. A balloon delivery system for delivering a treatment fluidto bladder tissue, comprising: a balloon catheter including a catheterbody having a distal treatment end, the distal treatment end including afirst inflation balloon; an second inflation balloon positioned withinthe inflation balloon; a third inflation balloon; and a plurality ofmicro needles formed on an exterior surface of the second inflationballoon, each micro needle defining a lumen and including a needle tipconfigured to puncture an inner bladder wall when the second inflationballoon is disposed in in an inflated disposition, wherein the treatmentfluid is located between the second inflation balloon and the thirdinflation balloon such that inflation of the third inflation balloondirects the treatment fluid through the micro needles and into the innerbladder wall.
 4. The balloon delivery system of claim 3, wherein eachmicro needle is defined within a recessed area on the exterior surface,the recessed area further comprising a pair of hinges with a hinge oneach side of the micro needle, wherein inflation of the second inflationballoon causes each recessed area to be directed outward with the pairof hinges directing each micro needle into the inner bladder wall. 5.The balloon delivery system of claim 3, wherein each micro needlecomprises a stiff dimple formed by passing a needle through an interiorsurface of the first inflation balloon and out the exterior surface suchthat said stiff dimple punctures the inner bladder wall with the secondinflation balloon is disposed in the inflated disposition.
 6. Theballoon delivery system of claim 3, wherein each micro needle isfabricated of a bioabsorbable or bioresorbable polymer and wherein eachmicro needle comprises a plurality of barbs such that each barb becomesembedded in the inner bladder wall with the second inflation balloon ina fully inflated disposition and whereupon said plurality of barbsretain each micro needle within the inner bladder wall as the secondinflation balloon is deflated and assumes an uninflated dispositioncausing each micro needle to break off of the exterior surface of thesecond inflation balloon.
 7. The balloon delivery system of claim 6,wherein the treatment fluid is administered into bladder tissue during atime period in which the bioabsorbable or bioresorbable polymer isbroken down by the bladder tissue.
 8. The balloon delivery system ofclaim 6, wherein each micro needle includes an internal reservoir forretaining the treatment fluid.
 9. The balloon delivery system of claim6, wherein the treatment fluid is included within the bioabsorbable orbioresorbable polymer during formation of each micro needle.
 10. Theballoon delivery system of claim 3, wherein the second inflation balloonincludes a plurality of wells arranged on an exterior surface with thetreatment fluid stored in the plurality of wells such that upon thesecond inflation balloon reaching a fully inflated state, the treatmentfluid is ejected from the plurality of wells for injection of thetreatment fluid through the plurality of micro needles.
 11. The balloondelivery system of claim 3, wherein said plurality of micro needles areformed directly on the second inflation balloon, wherein inflation ofthe second inflation balloon directs the micro needles to puncture thefirst inflation balloon as each micro needle is directed into the innerbladder wall.
 12. The balloon delivery system of claim 3, whereininflation of the second inflation balloon pressurizes the treatmentfluid.
 13. A balloon delivery system for delivering a treatment fluid tobladder tissue, comprising: a balloon catheter including a catheter bodyhaving a distal treatment end, the distal treatment end including aninflation balloon; and a lead structure positioned inside the inflationballoon, the lead structure including a lead lumen fluidly connected toa lead hub, the lead hub further comprising a plurality of flexibledelivery tubes fluidly connected to the lead hub, the lead structureincluding a plurality of micro needles where each micro needle isfluidly attached to a flexible delivery tube.
 14. The balloon deliverysystem of claim 13, wherein delivery of the treatment fluid through thelead lumen and into the lead hub directs the micro needles to deployoutwardly from the lead hub so as to puncture the inner bladder wall andwherein the treatment fluid is delivered through each flexible deliverytube such that the treatment fluid is injected through each micro needleand into the inner bladder wall.